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Rhu-pGSN for Severe Covid-19 Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358406
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
BioAegis Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE April 16, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date April 24, 2020
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
  • Efficacy: Proportion of subjects alive not on vasopressors, mechanical ventilator, and dialysis [ Time Frame: Day 14 ]
    Proportion of subjects alive not on vasopressors, mechanical ventilator, and dialysis
  • Safety and Tolerability: Proportion of subjects with serious adverse events (SAEs) [ Time Frame: Continuous through Day 28 ]
    Proportion of subjects with SAEs as judged by the investigator
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
  • Efficacy: All cause mortality rate though Day 28 [ Time Frame: Continuous through Day 28 ]
    All cause mortality rate using Kaplan-Meier survival analysis
  • Efficacy: Change in World Health Organisation (WHO) 9-point severity score [ Time Frame: Daily through at least Day 14 ]
    Change in the 9-point Severity Score (ordinal scale) proposed by a special WHO committee for COVID-19 pneumonia where a score of 8 indicates death and 0 is no clinical or virological evidence of COVID-19 infection
  • Efficacy: Proportion of subjects discharged to home or immediate prior residence [ Time Frame: Continuous through Day 28 ]
    Proportion of subjects discharged to home or immediate prior residence
  • Efficacy: Number of days alive and off the ventilator [ Time Frame: Continuous through Day 28 ]
    Number of days alive and off the ventilator
  • Efficacy: Length of stay (LOS) of surviving subjects in the hospital [ Time Frame: Continous through day 28 ]
    LOS in hospital (days) of surviving subjects
  • Efficacy: Proportion of subjects readmitted to the hospital [ Time Frame: Up to 90 days ]
    Proportion of subjects readmitted to the hospital
  • Safety and Tolerability: Proportion of subjects with Grade 3-4 clinically significant laboratory abnormalities. [ Time Frame: Continuous through Day 28 ]
    Clinically significant laboratory abnormalities graded according to the National Cancer Institute (NCI) as follows: Grade 0: No abnormalities, Grade 3: Moderate, Grade 4:Severe
  • Safety and Tolerability: Proportion of subjects with non-serious adverse events (AEs) [ Time Frame: Continuous through Day 28 ]
    Proportion of subjects with non-serious adverse events (AEs)
  • Immunogenicity: Proportion of subjects with anti-pGSN antibodies [ Time Frame: Days 0, 28, and 90 ]
    Proportion of subjects with anti-pGSN antibodies
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rhu-pGSN for Severe Covid-19 Pneumonia
Official Title  ICMJE A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof-Of-Concept Study To Evaluate Efficacy And Safety Of Recombinant Human Plasma Gelsolin (Rhu-pGSN) Added To Standard Of Care In Subjects With Severe Covid-19 Pneumonia
Brief Summary

Study Objectives:

Primary

  • To assess the efficacy (survival without organ failure) of three doses of rhu-pGSN to hospitalized subjects with a primary diagnosis of COVID-19 pneumonia
  • To evaluate the safety and tolerability of three doses of rhu-pGSN

Secondary

  • To examine individual components of the primary composite endpoint
  • To assess the relationship of pGSN levels at baseline with clinical outcomes
  • To assess changes in WHO 9 point severity score

Immunogenicity

• To investigate the development of antibodies against pGSN post-treatment

Detailed Description

Efficacy and safety of intravenous rhu-pGSN on top of standard of care will be evaluated initially in 60 participants representative of the drug target population: high-risk subjects with acute severe pneumonia due to COVID-19. The rhu-pGSN dose will be based on actual body weight given at 12 mg/kg. Three doses will be given at 0, 12 and 24 hours intervals promptly after enrollment by IV infusion through a 0.2 µ filter. Participants will be randomized 1:1 rhu-pGSN or placebo. Interim safety analyses will be conducted after enrollment of 12, 24, 36, and 48 patients.

The primary efficacy outcome will be the proportion of patients surviving on Day 14 without mechanical ventilation, vasopressors or dialysis. Secondary analyses will examine mortality and the composite endpoint at 14, 28 and 90 days. In addition, exploratory analyses will involve the number of days up to day 28 without respiratory, vasopressor or renal support separately, duration of IV and total antimicrobial therapy, medical costs, and outcomes by pathogen type. Baseline and sequential levels of pGSN and inflammatory biomarkers will be measured. On days 0, 28, and 90, immunogenicity due to the formation of anti-pGSN antibodies will be assessed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Randomized, blinded, placebo controlled interventional
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Treatment blinded to all but unblinded pharmacist
Primary Purpose: Treatment
Condition  ICMJE Sars-CoV2
Intervention  ICMJE
  • Drug: Recombinant human plasma gelsolin (Rhu-pGSN)
    Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
    Other Name: gelsolin
  • Other: Placebo
    Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
    Intervention: Other: Placebo
  • Active Comparator: Rhu-pGSN
    Recombinant human plasma gelsolin reconstituted for slow bolus injection.
    Intervention: Drug: Recombinant human plasma gelsolin (Rhu-pGSN)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Weight ≤100 kg
  2. Within 24 hours of reaching a WHO severity score of 4-6 either:

    1. At admission
    2. While already hospitalized
  3. Informed consent obtained from subject/next of kin/legal proxy
  4. Primary admitting diagnosis of pneumonia supported by a compatible clinical presentation with a documented infiltrate consistent with pneumonia on chest radiograph, CT, or MRI, as assessed by the admitting emergency-department (ED), clinic, or ward physician or equivalent caregiver

Recommended (not mandatory) guidance/discretionary criteria defining patients with pneumonia satisfying all 4 categories below:

  • At least 2 symptoms: difficulty breathing, cough, production of purulent sputum, or chest pain
  • At least 2 vital sign abnormalities: fever, tachycardia, or tachypnea (thresholds -- fever: oral or core temperature >100.4 F [38 C]; heart rate >100 beats/min; respiratory rate >24/min)
  • At least one finding of other clinical signs and laboratory abnormalities: hypoxemia (O2 saturation <90%), clinical evidence of pulmonary consolidation, or leukocytosis or leukopenia
  • Chest imaging, CT, or MRI showing new (or presumed new or worsening) pulmonary infiltrates PI to note radiologic findings in the CRF Radiology report to be placed in the CRF A copy of the radiograph attached to be saved for review

Exclusion Criteria:

  1. Requiring ECMO or WHO score >6 or <4
  2. Pregnant or lactating women
  3. Unable to understand and provide informed consent (written consent can be provided by next of kin or legal guardian on the patient's behalf)
  4. CURB-65 score <3
  5. Use of any investigational drug in the past 30 days
  6. Hospitalization during the last 30 days
  7. Active underlying cancer treated with systemic chemotherapy or radiation therapy during the last 30 days
  8. Transplantation of hematopoietic or solid organs
  9. Chronic mechanical ventilation or dialysis
  10. Active symptomatic congestive heart failure worse than stable baseline
  11. Myocardial infarction, pulmonary embolism, or cardiopulmonary arrest in last 30 days
  12. Weight >100 kg
  13. Otherwise unsuitable for study participation because of chronic, severe, end-stage, life-limiting underlying disease likely to interfere with management and assessment of acute pneumonia, is to receive only comfort or limited (non-aggressive) care, or has a life expectancy <6 months unrelated to acute pneumonia in the opinion of the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark J DiNubile, MD 609-706-5866 mdinubile@bioaegistx.com
Contact: Susan L Levinson, PhD 19735394552 slevinson@bioaegistx.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04358406
Other Study ID Numbers  ICMJE BTI-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party BioAegis Therapeutics Inc.
Study Sponsor  ICMJE BioAegis Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BioAegis Therapeutics Inc.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP